MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date provided was in august 2022.If explanted; give date: n/a (not applicable).The lens remains implanted.Device evaluation: the device was not returned at the manufacturing site as it remains implanted; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.An attempt was made to obtain the missing information; however, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient implanted with an intraocular lens (iol) in their right eye was having blurred vision.Through follow-up, it was learned that the patient started having blurry vision about 2 months ago.The patient confirmed her visual issue is not debilitating, but more of an annoyance.The patient has only received glasses in january.No other treatment reported.The lens remains implanted.Additional information was provided that the patient saw her doctor on (b)(6) 2022 and the doctor told her there is a bubble behind the lens and said it was normal.The patient went back to see her doctor on (b)(6) 2022 to remove the bubble.She said the doctor lasered her eye.The patient's vision was immediately much better and the patient is happy now.The patient did not know the name of the bubble, but said it is on her paperwork that she threw away.The patient confirmed the surgeon performed a yttrium aluminum garnet (yag) capsulotomy.No other information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15756250
• Report Number: 3012236936-2022-02771
• Device Sequence Number: 5127031
• Product Code: MJP
• UDI-Device Identifier: 05050474552043
• UDI-Public: (01)05050474552043(17)211218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female